General Electric (GE; Fairfield, Connecticut) last month said it has acquired all the outstanding shares of Amersham (Little Chalfont, UK), completing its $9.5 billion acquisition of the world leader in diagnostic imaging agents and other life sciences products. Combined with GE Medical Systems (Waukesha, Wisconsin) a leading global provider of medical imaging equipment, healthcare services and information technology the $14 billion business, now known as GE Healthcare, is expected to generate $16 billion in revenues in 2005 and employ more than 42,000 people worldwide.
With the completion of the transaction first announced by the companies last October, Sir William Castell, formerly chief executive of Amersham, assumes the role of president and chief executive officer of GE Healthcare. Joseph Hogan, senior vice president of GE, will continue to lead GE's $11 billion medical imaging, services and IT businesses, now named GE Healthcare Technologies. Peter Loescher, former chief operating officer of Amersham, will be named a GE officer and will manage the newly created $3 billion GE Healthcare Bio-Sciences business, which will consist of the former Amersham operating units. Both Hogan and Loescher will report directly to Castell. GE Healthcare will have its global headquarters in Chalfont St. Giles, UK. GE Healthcare Technologies will be headquartered in Waukesha and GE Healthcare Bio-Sciences will be headquartered in Little Chalfont.
"These technology and service-driven businesses can change the face of healthcare," said Jeffrey Immelt, chairman and chief executive officer of General Electric, who headed GE Medical before advancing to the top posts of the parent company in 2001. In a statement, Casteel lauded the "exciting new company" that has emerged from the combination of GE Medical and Amersham: "We are ready to become the world's best diagnostic company."
The transaction is GE's second deal in the medical technology arena in the past six months to be measured by billions. It completed its $2 billion acquisition of Instrumentarium (Helsinki, Finland) last October. According to GE, the newly formed GE Healthcare unit is "uniquely suited to shape a new age of medical care one that enables healthcare to move from after-the-fact treatment to before-the-onset care."
During a teleconference on the merger, Hogan, who also holds the titles of president and chief executive officer of GE Healthcare Technologies, and Dan Peters, acting chief operating officer of the medical diagnostics business of GE Healthcare Bio-Sciences, discussed GE Healthcare's heightened focus on understanding disease at the molecular level, detecting conditions such as heart disease, cancer and Alzheimer's earlier and more specifically, and enabling therapies that are tailored to a patient.
"What we do is we bring together a really unique collection of expertise," Hogan said, adding that the combination brings a company like the old GE Medical Systems "with engineering, physics and informatics" together with the expertise that Amersham brings, "which is biology and chemistry." He added, "It's the first time in the industry that these core competencies have been combined into one company."
Hogan noted that the goal with this combination is to develop a company with the technology to detect diseases earlier, "possibly before the onset of physical symptoms." He said that GE Healthcare will accomplish this by accelerating the development of molecular imaging and personalized medicine by more rapidly developing and bringing to market new targeted imaging agents and diagnostics. "Overall, our vision is to strive to see life more clearly and to help healthcare providers better understand and diagnose and treat their patients," he said, adding, "the quality of life is being improved dramatically by this type of process."
Hogan said that the three primary areas the new company will focus its technology around are cancer, heart disease and neurology. He noted that GE Healthcare's goal is not to treat a disease. "Our goal is to partner with pharmaceutical companies and other types of therapeutic companies to help to treat disease." The company hopes to evolve medicine from the "see and treat" modality of the 20th century to a "predict and prevent" methodology and to move as aggressively as possible down that new pathway, which he characterized as a "new age of medicine."
As for its relationship with Varian Medical Systems (Palo Alto, California), a company that manufactures integrated cancer therapy systems and also is a supplier of X-ray tubes and flat-panel digital subsystems for imaging in medical, scientific and industrial applications, Hogan said that company's non-invasive approach to treating disease fits in well with the GE Healthcare strategy. "What's wonderful about Varian technology is that it is non-invasive," he said, adding that with new applications and new technologies such as IMRT (intensity-modulated radiation therapy) that it just introduced, "[Varian] can deliver that kind of ionized radiation in doses that are much more specific around patients and with much better outcomes."
He said that while his company's goal is to prevent progression of disease, he admitted that on the therapeutic side, he couldn't envision a time in his life at least "when all disease will be addressed way upstream." In the example of cancer treatment, Hogan said that GE never intended to become a therapeutic company. "What we're trying to do is bring visualization into therapeutics as much as we can because as you get feedback through our imaging technology, you can deliver therapies much more specifically than you could before, and that's where we add value and that's why our relationship with Varian is so good."
Asked about the potential resistance of conventional medicine to this new treatment approach, particularly with the concerns about holding down the cost of healthcare by government and third-party payors, Hogan said that the idea that prediction would increase the cost of medicine is an incorrect association. In fact, he said he believes it will have the opposite affect. "I really feel that by predicting and entering in early on before the onset of physical symptoms, you can actually reduce the overall cost to healthcare." Peters added that predictive medicine "should allow earlier treatment [and] should allow us to stop diseases before they progress." He added that in so doing, prediction should be effective in not only reducing the cost of healthcare, "but potentially improving the quality of life for all people involved and that's what we're really going after here."
Neoprobe pursues BLA on RIGS
Neoprobe (Dublin, Ohio) said last month that it is reinitiating the pursuit of a Biologic License Application (BLA) for FDA approval of its RIGS (Radio Image- Guided Surgery) technology, and it reported results from a discussion with the agency regarding the BLA in a conference call with investors. President and Chief Executive Officer David Bupp said that, in addition to reopening discussion with the FDA about the investigational RIGS technology, the meeting also "defined the pathway for the diagnostic and prognostic indications in colorectal cancer," which the company intends to pursue.
Bupp described the RIGS system as "a technique that enables the surgeon, while in surgery, to identify and delineate cancerous tissue targeted by a radionucleide bound to a tumor-specific binding target agent, thereby improving patient treatment and outcome." The system combines the hand-held gamma radiation detection probe and disease-specific radio-labeled cancer targeting agents, in combination with the surgical technique.
"We undertook the process of reinvigorating the RIGS technology due to two major developments," Bupp said. "First, the emergence of survival data from RIGS clinical trials in both recurrent and primary colorectal studies emerged from clinical investigators that confirmed the prognostic nature of RIGS-positive tissue. Review of the data with colorectal thought leaders established the viability of the market and the potential importance of the technology to clinicians and to patients." The second major finding, he said, was "a significant volume" of scientific and clinical data that has emerged concerning the importance of the presence of sialomucin in lymph nodes as being a predictor of lymph nodes becoming immune-compromised. "The antibodies used by Neoprobe in the RIGS technology target the Tag 72 antigen, or sialomucin," Bupp said, noting that with these data points in mind, the company "successfully re-engaged the FDA to review the RIGS program."
Neoprobe began clinical studies using RIGS in patients with current and primary colorectal cancer in 1993. The company conducted two large clinical trials in current and primary colorectal cancer patients from 1993 to 1996, with "the large global objective" of the two trials being the intraoperative detection of abdominal colorectal cancer, Bupp said. In addition to evaluating product safety, those studies compared RIGS information against diagnostic modalities involving traditional techniques of computed tomography (CT) scan and surgical exploration. Even though the studies were considered successful in meeting their endpoints, he said the commercial potential of the RIGS technology at that time was considered fairly limited. "The development program for the RIGS technology was put on hold in 1998, because a viable commercial strategy was lacking."
One of the primary objectives of meeting with the FDA was to confirm that Neoprobe still has an active BLA before the agency, he said, and the FDA confirmed that it did. The FDA declined a request to allow the company to amend the BLA to include survival data from the second RIGS Phase III trial, NEO2-13, which was conducted in primary colorectal cancer patients. The agency did agree to work with Neoprobe to design a single additional Phase III study to be combined with data from NEO2-14 "to meet diagnostic and prognostic clinical endpoints of all colorectal patients, both recurrent and primary," Bupp said.
Study: InterStim benefits fecal incontinence
A new study suggests that Medtronic's (Minneapolis, Minnesota) InterStim treatment for urinary incontinence also is beneficial for treating the socially debilitating condition of fecal incontinence. Published in the European medical journal The Lancet, the study suggests that sacral nerve stimulation significantly aids people suffering from fecal incontinence. Patients in the study not only reported fewer incidences of incontinence, but as a consequence they also reported improvements in lifestyle. Medtronic said the condition affects an estimated 2% of the general population. Prevalence increases with age, affecting 11% of men and 26% of women over 50.